Status:
TERMINATED
Endobronchial Valve for Emphysema PalliatioN Trial (VENT) Cost-effectiveness Sub-Study
Lead Sponsor:
Emphasys Medical
Conditions:
Emphysema
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
40-75 years
Phase:
PHASE3
Brief Summary
The purpose of the VENT Cost-Effectiveness Sub-Study is to gather healthcare utilization and quality of life information on patients enrolled in the VENT study in order to analyze the relative cost-ef...
Detailed Description
Therapeutic interventions in health care require the use of resources. Since these resources are limited, it is important for clinical decision-makers to have economic information in addition to safet...
Eligibility Criteria
Inclusion
- Diagnosed by high-resolution computed tomography (HRCT) with eligible heterogeneous disease distribution
- Forced expiratory volume in 1 second (FEV1) \< 45% predicted
- Total lung capacity (TLC) \> 100% predicted
- Residual volume (RV) \> 150% predicted
- Post rehabilitation 6 minute walk test \> 140m
- Non-smoking for 4 months
Exclusion
- Prior lung transplant, lung volume reduction surgery (LVRS), median sternotomy, bullectomy or lobectomy
- History of recurrent respiratory infections
- Evidence of large bullae (\> 30% of either lung) in a non-target lobe
- FEV1 \< 15% predicted
- Diffusing capacity of the lung for carbon monoxide (DLCO) \< 20% predicted
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT00137956
Start Date
December 1 2004
Last Update
August 18 2009
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